What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis, such as glucocorticoids, cyclophosphamide, and rituximab, have several known side effects. Glucocorticoids can cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Cyclophosphamide is associated with bone marrow suppression, increased risk of infections, hemorrhagic cystitis, and potential infertility. Rituximab can lead to infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy (PML). These side effects highlight the need for careful monitoring and management during treatment.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory and anti-inflammatory drugs for the treatment of Lupus Nephritis. Notably, belimumab (Benlysta) is an FDA-approved monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and is used to treat systemic lupus erythematosus (SLE) and Lupus Nephritis. Additionally, voclosporin (Lupkynis) is an FDA-approved calcineurin inhibitor that has shown efficacy in treating Lupus Nephritis by modulating the immune response and reducing inflammation. These treatments, like Zetomipzomib, aim to control the immune system's activity to prevent kidney damage.

What other types of research exist?

Promising novel alternatives to Zetomipzomib for Lupus Nephritis patients include: <ol> <li>Voclosporin: An immunosuppressant that has shown efficacy in achieving renal response in LN patients.</li> <li></li> </ol> Belimumab: A monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and has been approved for systemic lupus erythematosus (SLE) with potential benefits in LN. 3. Obinutuzumab: A monoclonal antibody targeting CD20, currently being investigated for its efficacy in LN. 4. Anifrolumab: A monoclonal antibody targeting the type I interferon receptor, showing promise in SLE and potentially beneficial for LN.

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Zetomipzomib for Lupus Nephritis

Phase 2

Waitlist Available

Led By Steven Kimmel, MD

Research Sponsored by Kezar Life Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test

Be older than 18 years old

Must not have

Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions)

Has received dialysis within the 52 weeks prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 13, week 25, week 37, and week 53

Summary

This trial is testing whether injections of zetomipzomib can help reduce kidney problems in people with lupus nephritis. The study includes patients who have active kidney inflammation due to lupus and are already receiving other treatments. Zetomipzomib works by calming the immune system to prevent further kidney damage.

Who is the study for?

This trial is for adults with active lupus nephritis, a kidney condition caused by systemic lupus erythematosus. Participants must have a BMI of ≥18, proper organ function, and confirmed diagnosis through biopsy within the last year. They should not have central nervous system SLE effects, transplants planned or done recently, certain infections like HIV or hepatitis B/C, intolerance to specific medications used in treatment (MMF/corticosteroids), other autoimmune conditions that could interfere with results, recent serious blood disorders or malignancies except some skin cancers.

What is being tested?

The study tests the effectiveness and safety of zetomipzomib at two doses (30 mg and 60 mg) versus a placebo over one year in achieving renal response in patients with active lupus nephritis. It aims to see if this drug can help manage kidney inflammation associated with lupus more effectively than no treatment.

What are the potential side effects?

While the side effects of zetomipzomib are not detailed here, similar drugs often cause immune system reactions, potential liver issues due to medication processing demands on the body's detoxification systems; gastrointestinal disturbances as common responses to foreign substances; fatigue from bodily resources being directed towards healing processes; and possible impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a positive ANA or anti-dsDNA test result.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at high risk for serious bleeding or organ issues needing immediate treatment.

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I have been on dialysis in the last year.

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I am allergic or cannot tolerate MMF or steroids.

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I have or had brain or nerve symptoms due to lupus.

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I have had or am planning to have a solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 13, week 25, week 37, and week 53

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 13, week 25, week 37, and week 53

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 13, week 25, week 37, and week 53 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate safety of zetomipzomib

To evaluate the efficacy of zetomipzomib

Secondary study objectives

CRR

Partial Renal Remission (PRR)

Other study objectives

CRR and no prednisone use

CRR and successful prednisone taper

CRR with UPCR ≤ ULN

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: zetomipzomib 60 mg + standard-of-careExperimental Treatment1 Intervention

Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period.

Group II: zetomipzomib 30 mg + standard-of-careExperimental Treatment1 Intervention

Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.

Group III: placebo + standard-of-carePlacebo Group1 Intervention

Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lupus Nephritis (LN) include immunomodulatory and anti-inflammatory agents. Immunomodulatory treatments, such as cyclophosphamide and mycophenolate mofetil, work by suppressing the immune system to reduce the production of autoantibodies that attack the kidneys. Anti-inflammatory treatments, like corticosteroids, reduce inflammation and immune activity, thereby decreasing kidney damage. Zetomipzomib, an investigational drug, likely functions through similar mechanisms by modulating immune responses and reducing inflammation. These treatments are crucial for LN patients as they help to preserve kidney function, prevent progression to kidney failure, and improve overall disease outcomes.